| CTRI Number |
CTRI/2018/04/013544 [Registered on: 27/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
evaluating changes in the joint present in front of ear in patients with no problem using dental radiographs |
|
Scientific Title of Study
|
Assessment of condylar changes in asymptomatic temporomandibular joints using digital panoramic radiography - A descriptive epidemiological study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D R CHANDINI |
| Designation |
Post Graduate |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral Medicine and Radiology
Room 1
Block III
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9703743027 |
| Fax |
|
| Email |
dr.chandini29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Mahadev Naik |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral Medicine and Radiology
Room 1
Block III
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8861255457 |
| Fax |
|
| Email |
dr.raghmn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra Mahadev Naik |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral Medicine and Radiology
Room 1
Block III
Vishnu Dental College
Vishnupur
Bhimavaram
ANDHRA PRADESH
534202
India |
| Phone |
8861255457 |
| Fax |
|
| Email |
dr.raghmn@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr D R Chandini |
| Address |
Department of Oral Medicine and Radiology
Room 1
Block III
Visnu Dental College
Vishnupur
Bhimavaram 534202 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D R Chandini |
Vishnu Dental College |
Department of Oral Medicine and Radiology
Room 1
Block III
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH |
9703743027
dr.chandini29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Temporomandibular disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged between 20 to 70 yrs.
2) Asymptomatic subjects with TMD.(Patients who are not aware of joint problems but can be diagnosed through radiograph)
|
|
| ExclusionCriteria |
| Details |
1)Subjects with history of mandibular fractures and underwent surgery of mandible in the past.
2)Subjects with developmental anomalies affecting the growth of jaw or syndromes of craniofacial structures.
3)Subjects who underwent orthodontic treatment in the past.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine condylar morphological changes,condylar bone changes,asymmetry of condyle, in accordance with dentition status and their correlation with age and gender of patient using digital orthopantomograph. |
To determine condylar morphological changes,condylar bone changes,asymmetry of condyle, in accordance with dentition status and their correlation with age and gender of patient using digital orthopantomograph. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To evaluate condylar bone density in accordance with dentition status and their correlation with age and gender of patient using digital orthopantomograph.
2)To assess dentition status according to eichner’s index and their correlation with age and gender of patient using digital orthopantomograph. |
1)To evaluate condylar bone density in accordance with dentition status and their correlation with age and gender of patient using digital orthopantomograph.
2)To assess dentition status according to eichner’s index and their correlation with age and gender of patient using digital orthopantomograph. |
|
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Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/12/2015 |
| Date of Study Completion (India) |
29/07/2017 |
| Date of First Enrollment (Global) |
21/12/2015 |
| Date of Study Completion (Global) |
29/07/2017 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The
present descriptive epidemiological study was undertaken to determine condylar
morphological changes, bone changes, condylar asymmetry, condylar bone density in
asymptomatic temporomandibular joints using digital panoramic radiography among
subjects. A
total of 400 subjects (186 males and 214 females) within the age range of 20-70
years consisting of 5 age groups with 80 patients in each group who had
asymptomatic temporomandibular joints were included in the present study.
Digital OPG images were taken and analyzed using Digora software. For the obtained digital image, linear
measurements for condylar asymmetry and condylar bone density were drawn
digitally by using software tools and obtained data was subjected to
statistical analysis The parameters like bone changes, condylar morphology,
condylar asymmetry, condylar bone density were recorded and analysed using
chi-square, and one way anova analysis.The condylar shapes has found to be quite incongruous
in different age-groups. Round condylar morphology was observed higher in
younger and older age groups and flat shape was least frequent among
asymptomatic subjects in this study. Among condylar bone changes sclerosis was
seen higher in younger age group and deformity, flattening of condyles were
seen in older age group. Absence of asymmetry of condyles was observed in male
subjects while females showed presence of asymmetry of condyles. There
is insufficient data with respect to the condylar bone density of patients with
asymptomatic TMJs. The present study analyzed the bone density on OPGs, and
found the average condylar density in mixed South Indian population.There
is insufficient data with respect to the condylar bone density of patients with
asymptomatic TMJs. The present study analyzed the bone density on OPGs, and
found the average condylar density in mixed South Indian population. |